Life Science Success
On this podcast, you'll find interviews with high-performing successful individuals in Life Sciences. On a weekly basis, we cover their proven methods, principles, strategies, and mindsets to implement new technologies that scale to meet the needs of people in our world.
Life Science Success
Gregory Glover on Regulatory IP and the Fight for Market Exclusivity
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In this episode of the Life Science Success Podcast my guest is Dr. Gregory Glover, founder of the Pharmaceutical Law Group, a Washington, DC practice built at the intersection of FDA regulation and intellectual property.
00:00 Show Introduction
00:29 Meet Gregory Glover
01:15 Doctor to Lawyer Journey
03:00 Why Medical Training Helps
04:07 Hatch-Waxman Origins
08:13 Exclusivity Versus Patents
11:48 Where Hatch-Waxman Ages
14:21 Skinny Label Explained
20:23 Aligning Strategy Early
25:06 Sponsor Break
26:19 When to Start Lifecycle
27:51 What Competitors Can See
29:20 Lifecycle Management Basics
31:29 Manufacturing and Patents
33:22 Overlooked Exclusivity Plays
35:06 BPCIA and Biosimilars
38:09 Policy Misunderstandings
39:27 Who Greg Works With
40:27 Barriers to Maximizing IP
43:07 Funding Climate Effects
45:13 Rapid Fire Reflections
48:51 How to Reach Greg
49:27 Closing and Subscribe
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